Collaborative trial of prenatal thyrotropin-releasing hormone and corticosteroids for prevention of respiratory distress syndrome. Collaborative Santiago Surfactant Group.
OBJECTIVE
Our purpose was to determine whether adding antenatal thyrotropin-releasing hormone to prenatal corticosteroids reduces the frequency of respiratory distress syndrome.


METHODS
A randomized, multicenter, double-blind, placebo-controlled trial was conducted of thyrotropin-releasing hormone (400 micrograms intravenously every 8 hours four times) in women with singleton pregnancies < 33 weeks of gestation who received antenatal betamethasone (12 mg intramuscularly every 24 hours two times). Neonates weighing < 1.0 kg received prophylactic surfactant and those above that weight received rescue therapy.


RESULTS
One hundred ninety women received thyrotropin-releasing hormone and 180 were given placebo. There were no differences in the frequency of respiratory distress syndrome (relative risk 1.17 [95% confidence interval 0.93 to 1.48]), use of oxygen at age 28 days (1.14 [0.80 to 1.62]), or neonatal mortality (1.05 [0.79 to 1.38]). Air leaks were more frequent in the thyrotropin-releasing hormone group (1.57 [1.23 to 2.01]).


CONCLUSIONS
The combination of antenatal thyrotropin-releasing hormone and corticosteroids does not reduce the frequency of respiratory distress syndrome or improve the outcome of preterm neonates compared with the use of corticosteroids alone.
D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000627:therapeutic use*; D000328:Adult; D001623:Betamethasone / Q000008:administration & dosage / Q000627:therapeutic use; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004338:Drug Combinations; D005233:Fatty Alcohols / Q000627:therapeutic use; D005260:Female; D005333:Fetus / Q000378:metabolism; D006801:Humans; D015994:Incidence; D007231:Infant, Newborn; D007273:Injections, Intramuscular; D007275:Injections, Intravenous; D008429:Maternal Welfare; D010767:Phosphorylcholine; D011092:Polyethylene Glycols / Q000627:therapeutic use; D011247:Pregnancy; D011256:Pregnancy Outcome; D011388:Prolactin / Q000097:blood; D011663:Pulmonary Surfactants / Q000627:therapeutic use; D012127:Respiratory Distress Syndrome, Newborn / Q000097:blood / Q000453:epidemiology / Q000517:prevention & control*; D013963:Thyroid Hormones / Q000097:blood; D013973:Thyrotropin-Releasing Hormone / Q000008:administration & dosage / Q000627:therapeutic use*
D000305:Adrenal Cortex Hormones; D004338:Drug Combinations; D005233:Fatty Alcohols; D011663:Pulmonary Surfactants; D013963:Thyroid Hormones; D010767:Phosphorylcholine; D011092:Polyethylene Glycols; D013973:Thyrotropin-Releasing Hormone; D011388:Prolactin; D001623:Betamethasone; C047049:dipalmitoylphosphatidylcholine, hexadecanol, tyloxapol drug combination